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Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study

NCT01306981 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-09-09

No results posted yet for this study

Summary

This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy.

Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Our hypothesis is that injection into the eye of ranibizumab one week before surgery will make the surgery easier, reduce complications and improve outcome.

In this trial, patients will be randomly allocated to receive either ranibizumab injection or a placebo injection of saline. Neither the patient, their surgeon, nor the study investigators will know which they have received so that a fair comparison can be made.

Conditions

Interventions

DRUG

Ranibizumab

Intravitreal injection of ranibizumab, 0.5mg in 0.05ml

DRUG

Saline

Subconjunctival injection of 0.05ml saline 0.9% w/v

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Moorfields Eye Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • James W Bainbridge, MA PhD FRCOphth · Moorfields Eye Hospital and UCL Institute of Ophthalmology Biomedical Research Centre for Ophthalmology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-30
Primary Completion
2013-03-31
Completion
2013-03-12

Countries

  • United Kingdom

Study Locations

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Entities

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01306981 on ClinicalTrials.gov